Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PKs) of ZYDPLA1 Following Oral Administration in Healthy Volunteers

Completed · Phase 1 · Has a placebo group

Conditions studied: Diabetes Mellitus

In brief

This First in Human (FIH) Phase I study intends to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ZYDPLA1 in normal healthy adult volunteers.

Key facts

Study ID

NCT02620592

Run by

Zydus Lifesciences Limited

People needed

84

Starts

2014-10-01

Expected to finish

2015-10-01

Last updated by the study team

2015-12-03

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy male or female between 18 and 65 years of age.
• Male subjects must agree to use one of the contraception methods during the study. Male contraceptive options include: Vasectomy, Abstinence requiring the use of contraceptives if becoming sexually active, or double barrier method (condom with spermicide, diaphragm or cervical cap). No Sperm donation for at least up to 90 days after last investigational product.
• BMI within the range 18.0 - 30.0 kg/m2 BMI value should be rounded off to one significant digit after decimal point. BMI values should be rounded to the nearest integer (ex. 30.4 rounds down to 30, while 17.5 rounds up to 18).
• Capable of giving written informed consent, which includes compliance with protocol.
• Corrected QT interval (QTc) interval < 450msec (as measured by QTcF)
• For gender effect study, only females with history of sterility or at least 1 year menopause or use of long acting non hormonal contraceptive measures (e.g., intrauterine device) will be recruited. Surgical sterility is defined as either bilateral tubal ligation/occlusion, bilateral oophorectomy or hysterectomy.
• Negative Urine drug screen including amphetamine, barbiturates, benzodiazepines, cannabinoid, cocaine, opiates, methadone and phencyclidine within 28 days prior to initiation of the study and prior to check-in.

You may not qualify if…

• Presence or history of pancreatitis at any time {Serum Amylase/Serum Lipase more than significant upper normal limit (≥1.5 times UNL)}
• Presence or history of severe gastrointestinal disease in the last 6 months
• Presence or history of renal insufficiency at any time {Serum creatinine more than upper normal limit (UNL)}
• Active liver disease and/or liver transaminases greater than 1.5 times UNL
• History or presence of other systemic disorders or diseases (e.g., respiratory, gastrointestinal, endocrine, immunological, dermatological, neurological, psychiatric disease or any other body system involvement)
• History or presence of any medication in the last 14 days
• History or presence of significant alcoholism or drug abuse within the past 1 year
• History or presence of significant smoking (more than 10 cigarettes per day) or consumption of tobacco products (more than 10 times per day)
• Difficulty with donating blood or difficulty in accessibility of veins.
• Intolerance to venipuncture.
• Systolic blood pressure more than 150 mmHg and less than 100 mmHg and diastolic blood pressure more than 90 mmHg
• Pulse rate less than 50/minute and more than 100/minute
• Any clinically significant laboratory findings during screening
• History or presence of any clinically significant electrocardiogram (ECG) abnormalities during screening as determined by the Principal Investigator.
• Major illness and/or major surgery in last 3 months
• Volunteers who have participated in any drug research study other than the present trial within the past 30 days (Subjected to Insurance that subject has not participated in long acting drug including new biological entities/new chemical entities/biosimilar products).
• Volunteers who have donated one unit (450 mL) of blood in the past 3 months
• Positive Alcohol breath analyzer at the time of Screening and Check-in
• A positive hepatitis screen (includes subtype B and C) and/or a positive test result for HIV antibody.
• Any food allergy, intolerance, restriction or special diet that, in the opinion of the Principal investigator or Sub-investigator, could contraindicate the study participant's participation in this study.
• For gender effect study, female volunteers with following criteria will not be recruited:
• History of pregnancy or lactation in the past 3 months
• Fertile female volunteers not protected against pregnancy by adequate long-term anti-fertility measures
• History of less than 1 year of menopause and not using adequate long-term antifertility measures
• Using hormonal contraceptives

Where it is running

• Profil Institute for Clinical Research — Chula Vista, California, United States

Full record on ClinicalTrials.gov

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